Trial Outcomes & Findings for A Study in Participants With Diabetic Kidney Disease (NCT NCT01113801)
NCT ID: NCT01113801
Last Updated: 2019-09-17
Results Overview
Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
417 participants
Primary outcome timeframe
Baseline, 12 months
Results posted on
2019-09-17
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo given subcutaneous (SC) injection monthly for 12 months
|
2 mg LY2382770
2 milligrams (mg) LY2382770 given (SC) injection monthly for 12 months
|
10 mg LY2382770
10 mg LY2382770 given SC injection monthly for 12 months
|
50 mg LY2382770
50 mg LY2382770 given SC injection monthly for 12 months
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
103
|
105
|
103
|
106
|
|
Overall Study
Received at Least One Dose of Drug
|
103
|
105
|
103
|
105
|
|
Overall Study
COMPLETED
|
62
|
65
|
66
|
65
|
|
Overall Study
NOT COMPLETED
|
41
|
40
|
37
|
41
|
Reasons for withdrawal
| Measure |
Placebo
Placebo given subcutaneous (SC) injection monthly for 12 months
|
2 mg LY2382770
2 milligrams (mg) LY2382770 given (SC) injection monthly for 12 months
|
10 mg LY2382770
10 mg LY2382770 given SC injection monthly for 12 months
|
50 mg LY2382770
50 mg LY2382770 given SC injection monthly for 12 months
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
0
|
2
|
6
|
|
Overall Study
Death
|
4
|
5
|
3
|
4
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
9
|
7
|
7
|
8
|
|
Overall Study
Physician Decision
|
2
|
2
|
3
|
3
|
|
Overall Study
Sponsor Decision
|
15
|
21
|
20
|
15
|
|
Overall Study
Clinical Endpoint (ESRD)
|
7
|
4
|
2
|
5
|
Baseline Characteristics
A Study in Participants With Diabetic Kidney Disease
Baseline characteristics by cohort
| Measure |
Placebo
n=103 Participants
Placebo given subcutaneous (SC) injection monthly for 12 months
|
2 mg LY2382770
n=105 Participants
2 milligrams (mg) LY2382770 given (SC) injection monthly for 12 months
|
10 mg LY2382770
n=103 Participants
10 mg LY2382770 given SC injection monthly for 12 months
|
50 mg LY2382770
n=105 Participants
50 mg LY2382770 given SC injection monthly for 12 months
|
Total
n=416 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.7 years
STANDARD_DEVIATION 11.31 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 9.20 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 9.05 • n=5 Participants
|
62.9 years
STANDARD_DEVIATION 10.86 • n=4 Participants
|
62.2 years
STANDARD_DEVIATION 10.16 • n=21 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
86 Participants
n=4 Participants
|
320 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
211 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
160 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
83 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
347 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Region of Enrollment
France
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
146 Participants
n=21 Participants
|
|
Region of Enrollment
Czechia
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Region of Enrollment
Hungary
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
57 Participants
n=21 Participants
|
|
Region of Enrollment
Puerto Rico
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
Australia
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Region of Enrollment
Israel
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
82 Participants
n=21 Participants
|
|
Serum Creatinine
|
2.209 milligram/deciliter (mg/dl)
STANDARD_DEVIATION 0.5917 • n=5 Participants
|
2.127 milligram/deciliter (mg/dl)
STANDARD_DEVIATION 0.5824 • n=7 Participants
|
2.091 milligram/deciliter (mg/dl)
STANDARD_DEVIATION 0.6538 • n=5 Participants
|
2.132 milligram/deciliter (mg/dl)
STANDARD_DEVIATION 0.6289 • n=4 Participants
|
2.140 milligram/deciliter (mg/dl)
STANDARD_DEVIATION 0.6141 • n=21 Participants
|
|
Urine Protein/Creatinine Ratio
|
3.123 gram/gram
STANDARD_DEVIATION 2.5180 • n=5 Participants
|
3.266 gram/gram
STANDARD_DEVIATION 2.5723 • n=7 Participants
|
3.301 gram/gram
STANDARD_DEVIATION 2.4510 • n=5 Participants
|
3.354 gram/gram
STANDARD_DEVIATION 2.5457 • n=4 Participants
|
3.262 gram/gram
STANDARD_DEVIATION 2.5148 • n=21 Participants
|
|
Estimated Glomerular Filtration Rate (eGFR)
|
33.835 milliliter/minute/1.73 meter squared
STANDARD_DEVIATION 11.0568 • n=5 Participants
|
35.705 milliliter/minute/1.73 meter squared
STANDARD_DEVIATION 11.7226 • n=7 Participants
|
36.358 milliliter/minute/1.73 meter squared
STANDARD_DEVIATION 12.5154 • n=5 Participants
|
35.945 milliliter/minute/1.73 meter squared
STANDARD_DEVIATION 12.0852 • n=4 Participants
|
35.464 milliliter/minute/1.73 meter squared
STANDARD_DEVIATION 11.8539 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 12 monthsPopulation: All randomized participants who received at least 1 dose of drug and had evaluable baseline and post baseline serum creatinine values.
Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.
Outcome measures
| Measure |
Placebo
n=85 Participants
Placebo given subcutaneous (SC) injection monthly for 12 months
|
2 mg LY2382770
n=90 Participants
2 mg LY2382770 given (SC) injection monthly for 12 months
|
10 mg LY2382770
n=91 Participants
10 mg LY2382770 given SC injection monthly for 12 months
|
50 mg LY2382770
n=82 Participants
50 mg LY2382770 given SC injection monthly for 12 months
|
|---|---|---|---|---|
|
Change in Log Transformed (In) Serum Creatinine From Baseline to 12 Month Endpoint
|
0.13 ln milligrams per deciliter [ln(mg/dL)]
Standard Error 0.019
|
0.18 ln milligrams per deciliter [ln(mg/dL)]
Standard Error 0.019
|
0.17 ln milligrams per deciliter [ln(mg/dL)]
Standard Error 0.019
|
0.17 ln milligrams per deciliter [ln(mg/dL)]
Standard Error 0.020
|
SECONDARY outcome
Timeframe: Baseline, 12 monthsPopulation: All randomized participants who received at least 1 dose of drug and had evaluable urine protein and creatinine ratio values.
Analysis of covariance (ANCOVA) model was used with treatment, visit, and treatment-by-visit interaction as fixed effects, subject as random effect, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.
Outcome measures
| Measure |
Placebo
n=82 Participants
Placebo given subcutaneous (SC) injection monthly for 12 months
|
2 mg LY2382770
n=87 Participants
2 mg LY2382770 given (SC) injection monthly for 12 months
|
10 mg LY2382770
n=85 Participants
10 mg LY2382770 given SC injection monthly for 12 months
|
50 mg LY2382770
n=81 Participants
50 mg LY2382770 given SC injection monthly for 12 months
|
|---|---|---|---|---|
|
Change in Log Transformed (ln) Urine Protein/Creatinine Ratio From Baseline to 12 Month Endpoint
|
0.06 ln grams/grams [ln( g/g)]
Standard Error 0.076
|
0.05 ln grams/grams [ln( g/g)]
Standard Error 0.072
|
0.05 ln grams/grams [ln( g/g)]
Standard Error 0.073
|
-0.01 ln grams/grams [ln( g/g)]
Standard Error 0.075
|
SECONDARY outcome
Timeframe: Baseline through 12 months (samples collected pre and/or postdose at monthly intervals)Population: All randomized participants who received at least 1 dose of drug and had evaluable PK data.
Outcome measures
| Measure |
Placebo
Placebo given subcutaneous (SC) injection monthly for 12 months
|
2 mg LY2382770
n=105 Participants
2 mg LY2382770 given (SC) injection monthly for 12 months
|
10 mg LY2382770
n=101 Participants
10 mg LY2382770 given SC injection monthly for 12 months
|
50 mg LY2382770
n=104 Participants
50 mg LY2382770 given SC injection monthly for 12 months
|
|---|---|---|---|---|
|
Population Pharmacokinetics (PK) - Model-Estimated Area Under the Concentration -Time Curve (AUC ) Over a Dosing Interval
|
—
|
54.4 microgram*hour per milliliter(µg•hr/mL)
Geometric Coefficient of Variation 49
|
197 microgram*hour per milliliter(µg•hr/mL)
Geometric Coefficient of Variation 45
|
957 microgram*hour per milliliter(µg•hr/mL)
Geometric Coefficient of Variation 44
|
SECONDARY outcome
Timeframe: Baseline through 12 monthsPopulation: All randomized participants who received at least 1 dose of drug.
Analysis of covariance (ANCOVA) model was used with treatment as fixed effects and baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) log transformed (ln) as covariates.
Outcome measures
| Measure |
Placebo
n=103 Participants
Placebo given subcutaneous (SC) injection monthly for 12 months
|
2 mg LY2382770
n=105 Participants
2 mg LY2382770 given (SC) injection monthly for 12 months
|
10 mg LY2382770
n=103 Participants
10 mg LY2382770 given SC injection monthly for 12 months
|
50 mg LY2382770
n=105 Participants
50 mg LY2382770 given SC injection monthly for 12 months
|
|---|---|---|---|---|
|
Log Transformed (ln) Serum Creatinine Slope of Change From Baseline Through 12 Months
|
0.01605 ln milligrams per deciliter(mg/dL)/month
Standard Error 0.002685
|
0.01408 ln milligrams per deciliter(mg/dL)/month
Standard Error 0.002731
|
0.01716 ln milligrams per deciliter(mg/dL)/month
Standard Error 0.002658
|
0.01337 ln milligrams per deciliter(mg/dL)/month
Standard Error 0.002712
|
SECONDARY outcome
Timeframe: Baseline through 12 monthsPopulation: All randomized participants who received at least 1 dose of drug.
Analysis of covariance (ANCOVA) model was used with treatment as fixed effects, baseline Serum Creatinine log transformed (ln) and first morning urine protein to creatinine ratio (PCR) ) log transformed (ln) as covariates.
Outcome measures
| Measure |
Placebo
n=103 Participants
Placebo given subcutaneous (SC) injection monthly for 12 months
|
2 mg LY2382770
n=105 Participants
2 mg LY2382770 given (SC) injection monthly for 12 months
|
10 mg LY2382770
n=103 Participants
10 mg LY2382770 given SC injection monthly for 12 months
|
50 mg LY2382770
n=105 Participants
50 mg LY2382770 given SC injection monthly for 12 months
|
|---|---|---|---|---|
|
Estimated Glomerular Filtration Rate (eGFR) Slope of Change From Baseline Through 12 Months
|
-0.3727 mL/min/1.73 m²/month
Standard Error 0.08599
|
-0.3664 mL/min/1.73 m²/month
Standard Error 0.08742
|
-0.5554 mL/min/1.73 m²/month
Standard Error 0.08512
|
-0.3980 mL/min/1.73 m²/month
Standard Error 0.08683
|
Adverse Events
Placebo
Serious events: 39 serious events
Other events: 57 other events
Deaths: 0 deaths
2 mg LY2382770
Serious events: 44 serious events
Other events: 67 other events
Deaths: 0 deaths
10 mg LY2382770
Serious events: 37 serious events
Other events: 62 other events
Deaths: 0 deaths
50 mg LY2382770
Serious events: 41 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=103 participants at risk
Placebo given subcutaneous (SC) injection monthly for 12 months
|
2 mg LY2382770
n=105 participants at risk
2 mg LY2382770 given (SC) injection monthly for 12 months
|
10 mg LY2382770
n=103 participants at risk
10 mg LY2382770 given SC injection monthly for 12 months
|
50 mg LY2382770
n=105 participants at risk
50 mg LY2382770 given SC injection monthly for 12 months
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Vascular disorders
Hypertension
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Vascular disorders
Hypertensive crisis
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Vascular disorders
Hypotension
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Vascular disorders
Orthostatic hypotension
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sweat gland tumour
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.97%
1/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Central nervous system lesion
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
2.9%
3/105 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Diabetic mononeuropathy
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Ischaemic stroke
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Renal and urinary disorders
Azotaemia
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Renal and urinary disorders
Nephropathy
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Renal and urinary disorders
Renal failure
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Renal and urinary disorders
Renal failure acute
|
1.9%
2/103 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
4.8%
5/105 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
2.9%
3/103 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
7.6%
8/105 • Number of events 10
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Renal and urinary disorders
Renal failure chronic
|
4.9%
5/103 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
3.8%
4/105 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Renal and urinary disorders
Renal impairment
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.9%
3/103 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
3.8%
4/105 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
2.9%
3/105 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Atrial fibrillation
|
3.9%
4/103 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Cardiac failure
|
4.9%
5/103 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
2.9%
3/103 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
3.9%
4/103 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.7%
6/105 • Number of events 8
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Myocardial infarction
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Pericardial effusion
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Eye disorders
Cataract
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Eye disorders
Corneal oedema
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Eye disorders
Macular hole
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Eye disorders
Posterior capsule rupture
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Gastritis
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Haematemesis
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Mallory-weiss syndrome
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
General disorders
Chest pain
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
General disorders
Chills
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
General disorders
Device failure
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
General disorders
Generalised oedema
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
General disorders
Multi-organ failure
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
General disorders
Non-cardiac chest pain
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
General disorders
Oedema peripheral
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
General disorders
Pyrexia
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
General disorders
Sudden death
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Bacteraemia
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Bronchiolitis
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Bronchopneumonia
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Cellulitis
|
1.9%
2/103 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Dermatitis infected
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Device related infection
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Furuncle
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Gangrene
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Orchitis
|
0.00%
0/76
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.2%
1/84 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/74
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/86
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Osteomyelitis
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Otitis externa
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Pneumonia
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
3.8%
4/105 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Sepsis
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Staphylococcal abscess
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Streptococcal urinary tract infection
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Tonsillitis
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.9%
3/103 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.97%
1/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/105
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/103
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
Other adverse events
| Measure |
Placebo
n=103 participants at risk
Placebo given subcutaneous (SC) injection monthly for 12 months
|
2 mg LY2382770
n=105 participants at risk
2 mg LY2382770 given (SC) injection monthly for 12 months
|
10 mg LY2382770
n=103 participants at risk
10 mg LY2382770 given SC injection monthly for 12 months
|
50 mg LY2382770
n=105 participants at risk
50 mg LY2382770 given SC injection monthly for 12 months
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.8%
7/103 • Number of events 7
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.7%
6/105 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
3.9%
4/103 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
4.8%
5/105 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Constipation
|
3.9%
4/103 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
7.6%
8/105 • Number of events 10
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
7.8%
8/103 • Number of events 8
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
4.8%
5/105 • Number of events 7
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.9%
4/103 • Number of events 8
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
9.5%
10/105 • Number of events 15
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
10.7%
11/103 • Number of events 14
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.7%
6/105 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
5/103 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
6.7%
7/105 • Number of events 8
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
4.9%
5/103 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
6.7%
7/105 • Number of events 8
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
4/103 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
2.9%
3/105 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
4.9%
5/103 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
7.6%
8/105 • Number of events 10
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
General disorders
Fatigue
|
7.8%
8/103 • Number of events 9
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
2.9%
3/105 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.8%
6/103 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
4.8%
5/105 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
General disorders
Local swelling
|
6.8%
7/103 • Number of events 7
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.95%
1/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
General disorders
Oedema peripheral
|
14.6%
15/103 • Number of events 15
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
19.0%
20/105 • Number of events 22
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
10.7%
11/103 • Number of events 11
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
4.8%
5/105 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Bronchitis
|
4.9%
5/103 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
7.6%
8/105 • Number of events 8
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
3.9%
4/103 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.7%
6/105 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Influenza
|
3.9%
4/103 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.7%
6/105 • Number of events 8
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
3.9%
4/103 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Nasopharyngitis
|
7.8%
8/103 • Number of events 8
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.7%
6/105 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
2.9%
3/103 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Upper respiratory tract infection
|
9.7%
10/103 • Number of events 11
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
10.5%
11/105 • Number of events 11
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
12.6%
13/103 • Number of events 16
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
10.5%
11/105 • Number of events 13
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Infections and infestations
Urinary tract infection
|
5.8%
6/103 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
9.5%
10/105 • Number of events 11
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.97%
1/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
2.9%
3/105 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.97%
1/103 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.7%
6/105 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
7.8%
8/103 • Number of events 8
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
3.8%
4/105 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
9.7%
10/103 • Number of events 16
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
12.4%
13/105 • Number of events 20
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
8.7%
9/103 • Number of events 25
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
6.7%
7/105 • Number of events 15
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.9%
4/103 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
6.7%
7/105 • Number of events 8
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.8%
6/103 • Number of events 7
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
2.9%
3/105 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
6/103 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
7.6%
8/105 • Number of events 8
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
8.7%
9/103 • Number of events 9
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
4.8%
5/105 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.9%
3/103 • Number of events 3
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.7%
6/105 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
3.9%
4/103 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
3.8%
4/105 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.9%
4/103 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
7.6%
8/105 • Number of events 11
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
3.9%
4/103 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
4.8%
5/105 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Dizziness
|
7.8%
8/103 • Number of events 9
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
7.6%
8/105 • Number of events 9
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
3.9%
4/103 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
8.6%
9/105 • Number of events 12
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Nervous system disorders
Headache
|
2.9%
3/103 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
6.7%
7/105 • Number of events 7
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
7.8%
8/103 • Number of events 9
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/105 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/27
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/21
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/29
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.3%
1/19 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/27
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/21
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/29
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.3%
1/19 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/27
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/21
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
0.00%
0/29
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.3%
1/19 • Number of events 1
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
6.7%
7/105 • Number of events 7
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
4.9%
5/103 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
8.6%
9/105 • Number of events 10
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.9%
4/103 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
3.8%
4/105 • Number of events 4
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
1.9%
2/103 • Number of events 2
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.7%
6/105 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
|
Vascular disorders
Hypertension
|
5.8%
6/103 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
5.7%
6/105 • Number of events 6
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
8.7%
9/103 • Number of events 9
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
4.8%
5/105 • Number of events 5
All randomized participants who received at least 1 dose of drug. All serious adverse events following randomization are reported.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60